Periodontal DiseasesNCT03809676
Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
An observational study of Periodontal Diseases and Heart Transplantation, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data. Read more about this study
- Who is it for?
- Ages 11 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Heart Transplantation
- What is being tested?
- periodontal examination
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Jan 2018to 10 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 40 transplant recipients and 40 systemically healthy patients were recruited
Who may be able to join
- Having heart transplantation surgery
- be clinically stable
Who cannot join
- History of periodontal treatment within the previous year,
- history of antibiotic use during the preceding 6 months,
- being clinically non-stable For healthy group Inclusion criteria
- being systemically healthy
- no history of periodontal treatment within the previous year
- no history of antibiotic use during the preceding 6 months exclusion criteria Having a systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Yasemin Sezgin
Ankara, Please Select..., 06690
About this study
Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.
Read the detailed description
Patients who had heart transplantion surgery at between 2003 to 2017 were screened during routine outpatient visits. The patients who have history of periodontal treatment within the previous year, history of antibiotic use during the preceding 6 months, clinically non-stable patients were excluded . 40 cardiac transplant patiets who met these criteria included into this study. Each member of the transplant group was mathched with a patient in the systemically healthy control group by age and gender and smoking status. 40 systemically healthy subjects with no history of periodontal treatment within the previous year and no history of antibiotic use during the preceding 6 months were recruited.
Medical Data Hospital records were reviewed and data were collected using a standardised form that included demographic information (age, gender) and medical information such as smoking history, presence of systemic disease, post transplant time, medication regimen/dosages. Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised anamnestic questionnaire. Questions were about their personal oral hygeine behaviour (toothbrush, dental floss etc.), whether their dental visit was routine or complaint-oriented. For the transplant group one more question about whether a dental check up or comprehensive dental treatment had occured before transplantation was added.
Clinical Examination In both groups, periodontal examination was performed by one calibrated periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved a comprehensive periodontal examination including plaque index (PI); gingival index (GI); gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment level (CAL).
According to the clinical and radiographic evaluation the patients were categorized due to their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis or periodontitis. Patients were diagnosed with periodontally healthy if they have <10% bleeding sites with probing depths ≤3 mm; whereas patients who have >10% bleeding sites with probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm, interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26
- Conditions
- Periodontal Diseases, Heart Transplantation
- Being tested
- periodontal examination
- Medical subject headings
- Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
periodontal examinationOther
clinical measurements were recorded
| Study group | Role | What they receive |
|---|---|---|
| heaart transplant recipients | Not described Receives: Other: periodontal examination | |
| healthy controls | Not described Receives: Other: periodontal examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
probing depth
measured form pocket depth to the gingival margin by periodontal probe
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start9 Jan 2018
- Primary completion10 Jan 2019
- Study completion10 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809676
- Sponsor's protocol ID
- BaskentU4
- Status last verified
- Jan 2019
- First submitted
- 17 Jan 2019
- Last updated
- 23 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Status and Dental Behavior of Heart Trasplant Recipients and Healthy Controls
- ClinicalTrials.gov ID
- NCT03809676
- Acronym / sponsor ID
- BaskentU4
- Conditions
- Periodontal Diseases, Heart Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 9 Jan 2018 (actual)
- Primary completion
- 10 Jan 2019 (actual)
- Study completion
- 10 Jan 2019 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Forty heart transplant recipients and forty age and sex mathced systemically healthy patients were included. Periodontal examination was performed and a questionnaire was applied to record demographic data, systemic health and dental behavior data.
Detailed description
Patients who had heart transplantion surgery at between 2003 to 2017 were screened during routine outpatient visits. The patients who have history of periodontal treatment within the previous year, history of antibiotic use during the preceding 6 months, clinically non-stable patients were excluded . 40 cardiac transplant patiets who met these criteria included into this study. Each member of the transplant group was mathched with a patient in the systemically healthy control group by age and gender and smoking status. 40 systemically healthy subjects with no history of periodontal treatment within the previous year and no history of antibiotic use during the preceding 6 months were recruited.
Medical Data Hospital records were reviewed and data were collected using a standardised form that included demographic information (age, gender) and medical information such as smoking history, presence of systemic disease, post transplant time, medication regimen/dosages. Assesment of Oral Hygeine Behaviour Patients were also asked to complete a standardised anamnestic questionnaire. Questions were about their personal oral hygeine behaviour (toothbrush, dental floss etc.), whether their dental visit was routine or complaint-oriented. For the transplant group one more question about whether a dental check up or comprehensive dental treatment had occured before transplantation was added.
Clinical Examination In both groups, periodontal examination was performed by one calibrated periodontist at the Deperatment of Periodontology, Başkent University. All subjects recieved a comprehensive periodontal examination including plaque index (PI); gingival index (GI); gingival recession (GR); bleeding on probing (BOP); Probing depth (PD); clinical attachment level (CAL).
According to the clinical and radiographic evaluation the patients were categorized due to their periodontal status. The patients were diagnosed with periodontally healthy, gingivitis or periodontitis. Patients were diagnosed with periodontally healthy if they have <10% bleeding sites with probing depths ≤3 mm; whereas patients who have >10% bleeding sites with probing depths ≤3 mm were diagnosed with gingivitis. Patients who had probing depths ≥ 4 mm, interproximal, CAL of ≥2 mm or ≥3 mm at ≥2 non-adjacent teeth .9,25,26
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heaart transplant recipients | – | Other: periodontal examination |
| healthy controls | – | Other: periodontal examination |
Who may qualify
- Ages
- 11 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 40 transplant recipients and 40 systemically healthy patients were recruited
Key inclusion criteria (2 listed)
- Having heart transplantation surgery
- be clinically stable
Key exclusion criteria (6 listed)
- History of periodontal treatment within the previous year,
- history of antibiotic use during the preceding 6 months,
- being clinically non-stable For healthy group Inclusion criteria
- being systemically healthy
- no history of periodontal treatment within the previous year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| periodontal examinationclinical measurements were recorded | Other | heaart transplant recipients, healthy controls |
Primary outcome
probing depth
Time frame: day 1
measured form pocket depth to the gingival margin by periodontal probe
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Periodontal Diseases and Heart Transplantation, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
probing depth (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2019.